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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Muscle, Powered
510(k) Number K853154
Device Name HV-4
Applicant
Robert Bosch Corp.
Flower Field Bldg. #17
Mill Pond Rd.
St. James,  NY  11780
Applicant Contact ANDREW SCHAEFFER
Correspondent
Robert Bosch Corp.
Flower Field Bldg. #17
Mill Pond Rd.
St. James,  NY  11780
Correspondent Contact ANDREW SCHAEFFER
Regulation Number890.5850
Classification Product Code
IPF  
Date Received07/29/1985
Decision Date 03/28/1986
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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